Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-28 @ 5:49 PM
Study NCT ID:
NCT05571904
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '(1) Patients had skin defects at functional sites or joint sites; (2) Patients aged 20-80 years; (3) The lateral thighs were chosen as the donor sites.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'healing time of the donor sites', 'timeFrame': '2 months post surgery', 'description': 'The complete healing time of the donor sites was defined as the day when 100% epithelialization was achieved,'}], 'secondaryOutcomes': [{'measure': 'life quality (36-item short form health survey scores)', 'timeFrame': 'Prior to surgery or at 6 months post-surgery', 'description': 'The life quality of patients was evaluated by the 36-item short form health survey (SF-36) scores (including General Health scores, Mental Health scores, Social Function scores, and Vitality scores). The minimum value is 0. The maximum value is 100. The higher score means a better outcome.'}, {'measure': 'pains scores (Visual Analogue Scales)', 'timeFrame': 'on Day 1 and Day 7 postoperatively', 'description': 'The degrees of pain at the donor sites were evaluated by the Visual Analogue Scales. Patients were asked to score levels of pain (0 = no pain, 5 = worst pain) using Visual Analogue Scales. The higher score means a worse outcome.'}, {'measure': 'pruritus scores', 'timeFrame': 'at 3 months and at 6 months post-surgery', 'description': 'The degrees of pruritus at the donor sites were measured by scores (1 = never or occasional itches, 2 = itches do not disturb sleep, 3= itches disturb sleep). The higher score means a worse outcome.'}, {'measure': 'scars scores ( Vancouver Scar Scales )', 'timeFrame': 'at 3 months and 6 months post-surgery', 'description': 'The scar formation at the donor sites were evaluated with the Vancouver Scar Scales (from 0 to 15, 0 = best and 15 = worst) in terms of pigmentation, vascularity, pliability and height. The higher score means a worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['donor site', 'thick split-thickness skin graft', 'thin split-thickness skin graft', 'reconstruction'], 'conditions': ['Reconstruction']}, 'referencesModule': {'references': [{'pmid': '26615713', 'type': 'BACKGROUND', 'citation': 'Bian Y, Sun C, Zhang X, Li Y, Li W, Lv X, Li J, Jiang L, Li J, Feng J, Li XY. Wound-healing improvement by resurfacing split-thickness skin donor sites with thin split-thickness grafting. Burns. 2016 Feb;42(1):123-130. doi: 10.1016/j.burns.2015.07.008. Epub 2015 Nov 23.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/26615713/', 'label': 'Pubmed'}]}, 'descriptionModule': {'briefSummary': 'In clinical settings, split-thickness skin graft (STSG) remain the gold standard for covering large skin defects. However, STSGs usually bring complications to the donor sites. The study objective was to compare the efficacy of thick split-thickness skin graft versus thin split-thickness skin graft in the reconstruction of the donor site.', 'detailedDescription': 'All patients were randomly divided into two groups. For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique). For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients. The 36-item short form health survey (SF-36) scores, pain scores, pruritus scores, scar scores and rates of complications were compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients had skin defects at functional sites or joint sites.\n2. Patients aged 20-80 years.\n3. The lateral thighs were chosen as the donor sites.\n\nExclusion Criteria:\n\n1. Patients who were unable to complete the follow-up.\n2. Pregnant or nursing mothers were not included.\n3. Patients had an alternative source of pain other than surgical sites.\n4. Patients with organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or cancers.\n5. Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.\n6. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.\n7. Other reasons."}, 'identificationModule': {'nctId': 'NCT05571904', 'briefTitle': 'The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Comparison of Thick Split-thickness Skin Graft Versus Thin Split-thickness Skin Graft in the Reconstruction of the Donor Site', 'orgStudyIdInfo': {'id': 'KY20220701-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the thick STSG group', 'description': 'For the patients in the thick STSG group, the surgeons harvested thick STSGs which were larger than recipient sites. The extra skin was punctured and stretched to cover the donor site (the novel technique).', 'interventionNames': ['Procedure: thick STSG; thin STSG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the thin STSG group', 'description': 'For the patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with thin STSGs which were harvested from other parts of the patients.', 'interventionNames': ['Procedure: thick STSG; thin STSG']}], 'interventions': [{'name': 'thick STSG; thin STSG', 'type': 'PROCEDURE', 'description': 'For all the patients, thick STSGs (at a depth of 0.7 mm) were harvested from the upper lateral thighs to repair skin defects at functional sites or joint sites. For patients in the thick STSG group, the surgeons harvested a larger size of thick STSGs than the size of recipient sites. The size of the donor site was 150% - 200% of the size of the recipient site. Part of the thick STSG was grafted onto the recipient site. Subsequently, the leftover skin was punctured (in 1.5:1 mesh ratio) and stretched to obtain expansion. The donor site was covered by the leftover skin completely. In other words, the donor site was reconstructed by resurfacing the large sheet of thick STSG in situ.\n\nFor patients in the thin STSG group, the surgeons harvested thick STSGs of the size of recipient sites. Their donor sites were covered with a large sheet of thin STSGs (at a depth of 0.4 mm) which were harvested from other parts of the patients.', 'armGroupLabels': ['the thick STSG group', 'the thin STSG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yin Wu, phD', 'role': 'CONTACT', 'email': 'medwuyin@163.com', 'phone': '18305155832'}, {'name': 'Chao Hao, MD', 'role': 'CONTACT', 'email': 'haochao@163.com', 'phone': '15905166117'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yin Wu, phD', 'role': 'CONTACT', 'email': 'medwuyin@163.com', 'phone': '18305155832'}], 'overallOfficials': [{'name': 'Rong Wu, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.stats.gov.cn/tjsj/', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'December,31,2023', 'ipdSharing': 'YES', 'description': 'The study protocol, Iinformed Consent Form will be shared on the website:http://www.stats.gov.cn/tjsj/', 'accessCriteria': 'no limits'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital', 'investigatorFullName': 'YinWu', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}